Genetic Analysis in Identifying Late-Occurring Complications in Childhood Cancer Survivors

a study on Malignant Neoplasm Neoplasms

Summary

Eligibility
for people ages up to 99 years (full criteria)
Location
at Oakland, California and other locations
Dates
study started
Principal Investigator
by Carla B. Golden

Description

Summary

This clinical trial studies cancer survivors to identify those who are at increased risk of developing late-occurring complications after undergoing treatment for childhood cancer. A patient's genes may affect the risk of developing complications, such as congestive heart failure, avascular necrosis, stroke, and second cancer, years after undergoing cancer treatment. Genetic studies may help doctors identify survivors of childhood cancer who are more likely to develop late complications.

Official Title

Key Adverse Events After Childhood Cancer

Details

PRIMARY OBJECTIVES:

  1. To identify key adverse events developing in patients (cases) with a primary cancer diagnosed at age 21 or younger.

II. To characterize the key adverse events with respect to the nature of the primary malignancy (pathology, stage) and coded details of the therapeutic protocol.

III. To identify treatment-related and demographic risk factors through a direct comparison of the case-group and controls identified from the remaining patients with the same primary diagnosis.

IV. To compare the frequency of mutations or polymorphisms in specific candidate genes in cases and controls, using constitutional deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) from the cases and controls.

  1. To explore the role and nature of gene-environment interaction in the development of key adverse events.

OUTLINE:

DNA and RNA from peripheral blood or saliva sample of patients is analyzed for the presence of polymorphisms in genes associated with an increased risk of late-occurring complications.

Keywords

Childhood Malignant Neoplasm, Neoplasms, Laboratory Biomarker Analysis

Eligibility

For people ages up to 99 years

Inclusion Criteria:

  • ELIGIBILITY CRITERIA - CASES
  • Diagnosis of primary cancer at age 21 or younger, irrespective of current age
  • No prior history of allogeneic (non-autologous) hematopoietic cell transplant
  • Development of one of the following key adverse events at any time following initiation of cancer therapy:
    • Cardiac dysfunction; please note: case enrollment has been closed due to achievement of target accrual
    • Ischemic stroke (IS)
    • Subsequent malignant neoplasm (SMN)
    • Avascular necrosis (AVN); please note: case enrollment has been closed due to achievement of target accrual
  • Submission of a blood specimen (or in certain cases a saliva specimen) to the Coordinating Center at the University of Alabama at Birmingham as per the requirements; please note: if a patient is currently receiving active cancer treatment, it is preferable to obtain the blood sample at a time when the patient's white blood cell (WBC) is > 2,000
  • Written informed consent from the patient and/or the patient's legally authorized guardian
  • In active follow up by a COG institution; active follow up will be defined as date of last visit or contact by a COG institution within the past 24 months; any type of contact, including contact specifically for participation in ALTE03N1, qualifies as active follow-up; please note: treatment on a COG (or legacy group) therapeutic protocol for the primary cancer is NOT required
  • ELIGIBILITY CRITERIA - CONTROLS
  • CONTROL: Diagnosis of primary cancer at age 21 or younger, irrespective of current age
  • CONTROLS: No prior history of allogeneic (non-autologous) hematopoietic cell transplant
  • CONTROLS: No clinical evidence of any of the following key adverse events:
    • Cardiac dysfunction (CD); please note: if a patient is currently receiving active cancer treatment, it is preferable to obtain the blood sample at a time when the patient's WBC is > 2,000
    • Ischemic stroke (IS)
    • Avascular necrosis (AVN)
    • Subsequent malignant neoplasm (SMN)
  • CONTROLS: Submission of a blood specimen (or in certain cases a saliva specimen) to the Coordinating Center Laboratory at the University of Alabama at Birmingham as per the requirements
  • CONTROLS: Written informed consent from the patient and/or the patient's legally authorized guardian
  • CONTROLS: In active follow up by a COG institution; active follow up will be defined as date of last visit or contact by a COG institution within the past 24 months; any type of contact, including contact specifically for participation in ALTE03N1, qualifies as active follow-up; please note: treatment on a COG (or legacy group) therapeutic protocol for the primary cancer is NOT required

Locations

  • Children's Hospital and Research Center at Oakland accepting new patients
    Oakland California 94609-1809 United States
  • Kaiser Permanente-Oakland accepting new patients
    Oakland California 94611 United States
  • Valley Children's Hospital accepting new patients
    Madera California 93636 United States
  • Lucile Packard Children's Hospital Stanford University accepting new patients
    Palo Alto California 94304 United States

Lead Scientist at UCSF

Details

Status
accepting new patients
Start Date
Sponsor
Children's Oncology Group
ID
NCT00082745
Study Type
Observational
Participants
Expecting 3885 study participants
Last Updated
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